This randomized phase III trial studies OPT-821 and vaccine therapy to see how well they work compared with OPT-821 alone in treating patients with ovarian epithelial cancer, fallopian tube cancer, or peritoneal cancer that has decreased or disappeared, but the cancer may still be in the body. Biological therapies, such as OPT-821, may stimulate the immune system in different ways and stop tumor cells from growing. Vaccines may help the body build an effective immune response to kill tumor cells. It is not yet known whether OPT-821 is more effective with or without vaccine therapy in treating patients with ovarian epithelial cancer, fallopian tube cancer, or peritoneal cancer.

A Phase II Randomized, Double-Blind Trial of a Polyvalent Vaccine-KLH Conjugate (NSC 748933 ) + OPT-821 Versus OPT-821 in Patients With Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer Who Are in Second or Third Complete Remission

Progression-free survival (PFS) [ Time Frame: From randomization to the date of first clinical, biochemical, or radiological evidence of progression or death due to any cause, assessed up to 5 years ] [ Designated as safety issue: No ]

Characterized by treatment group with Kaplan-Meier plots and estimates of the median time until death or progression. A stratified log-rank test will be used to examine whether the two treatment groups are different after stratifying by second or third complete remission (CR). Second, a Cox proportional hazards model will be used to test the interaction of treatment arm and 2nd/3rd CR.

Analyses will be conducted on the measures of immune response to assess the effects of the study regimens on these endpoints and to determine whether these endpoints are associated with clinical outcomes (PFS and overall survival). Immune response will be measured at repeated time points (week 1 [prior to treatment], and weeks 11, 17, 23, 35, 47, 59, 71, and 83). Therefore, the relationship of immune response with PFS and overall survival will be examined with Cox proportional hazards models with immune response as a time-dependent covariate.

Frequency and severity of adverse events will be summarized with descriptive statistics for the patients in the safety analysis dataset.

Overall survival [ Time Frame: From entry onto the protocol to death due to any cause, or for living patients, date of last contact, assessed up to 5 years ] [ Designated as safety issue: No ]

Will be characterized by treatment group with Kaplan-Meier plots and estimates of the median time until death. The log rank test will be used to compare treatment groups with respect to overall survival.

I. To determine if a polyvalent vaccine (including GM2-keyhole limpet hemocyanin [KLH], Globo-H-KLH, Tn-mucin 1 [MUC1]-32mer-KLH, and Thompson Friedreich antigen [TF]-KLH plus OPT-821) decreases the hazard of progression or death compared to a vaccine containing OPT-821 alone in women with epithelial ovarian, fallopian tube, or peritoneal cancer in second or third complete clinical remission.

SECONDARY OBJECTIVES:

I. To compare the treatment arms with respect to the incidence of toxicities. II. To determine if the polyvalent vaccine decreases the hazard of death compared to a vaccine containing OPT-821 alone in women with epithelial ovarian, fallopian tube, or peritoneal cancer in second or third complete clinical remission.

TERTIARY OBJECTIVES:

I. To evaluate the immune response (by enzyme linked immunosorbent assay [ELISA]) in participants, in order to determine if the outcome correlates with antigen-specific immune titers.

After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Eligibility

Ages Eligible for Study:

18 Years and older (Adult, Senior)

Genders Eligible for Study:

Female

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Patients with histologically documented epithelial carcinoma arising in the ovary, fallopian tube, or peritoneum, of any stage or grade at diagnosis; all patients must have had cytoreductive surgery and chemotherapy with at least one platinum-based chemotherapy regimen as part of primary treatment

Patients who recurred on or after initial therapy, and are now in a second or third complete clinical remission and who are within four months of their last treatment are eligible; complete clinical remission is defined as serum cancer antigen (CA)-125 within institutional normal limits, negative physical examination, and no definite evidence of disease by computed tomography (CT) of the abdomen and pelvis; lymph nodes and/or soft tissue abnormalities =< 1.0 cm are often present in the pelvis and will not be considered definite evidence of disease; eligibility is determined by anatomical imaging only (ie. magnetic resonance imaging [MRI] or CT); a positive positron emission tomography (PET) image (if performed) will not exclude a patient if other criteria are met and anatomical imaging is negative

Absolute neutrophil count (ANC) greater than or equal to 1,000/mm^3, equivalent to Common Toxicity Criteria for Adverse Events (CTCAE version [v]4.0) grade 1

Patients must have a Gynecological Oncology Group (GOG) performance status of 0, 1, or 2

Patients who have signed the informed consent document and signed the authorization permitting release of personal health information

Patients of childbearing potential must have a negative serum pregnancy test prior to study entry and must be practicing an effective form of birth control; nursing mothers are excluded

Exclusion Criteria:

With the exception of non-melanoma skin cancer, patients with other invasive malignancies who had (or have) any evidence of the other cancer present within the last 5 years or whose previous cancer treatment contraindicates this protocol therapy are excluded

Patients whose circumstances at the time of entry onto the protocol would not permit completion of study or required follow up

Patients who have an allergy to shellfish

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00857545